Draft Patent Rules could Hit Public Health Safeguards, say Experts

Mumbai: Public health groups and patent lawyers have voiced concerns on the Draft Patents (Amendment) Rules, 2023, saying they could undermine public health safeguards and risk the availability of affordable generic medicines for patients in India.

The proposed amendments could potentially dilute critical protections — affecting people's right to file pre-grant opposition, the accessibility of compulsory licenses, and transparency in the patent system, they say.

Undermining crucial provisions like Form 27 (working of the patent) and Rule 55 (pre-grant opposition) are “unacceptable to patient groups’’ and a “clear attack’’ on the public health safeguards enshrined in India’s patent laws.

Discussions have been ongoing with stakeholders for almost a year to finalise the Draft Patents (Amendment) Rules, which aim to streamline the operations of the patent office and expedite processing timelines. The draft was made public for the promotion of industry and internal trade on August 23, inviting stakeholder comments.

Patients’ groups, civil society organisations, and public health experts are calling on the government to consider these concerns and revise the proposed draft to ensure that the safeguards enshrined in India’s patent system are protected to ensure public health and access to affordable medicines. “We will be submitting these concerns by September 22,’’ a patent expert told TOI, adding that the consultations were lopsided with hardly any patient groups having been part of the exercise.

One of the major tweaks is in Rule 55 — opposing the patent before its grant. Pre-grant opposition is an important public health safeguard against patent evergreening and unmerited monopolies, and ensures that quality-assured and affordable generics remain accessible. The amendment introduces a dynamic and exorbitant fee for filing pre-grant oppositions and granting excessive authority to the Controller to determine the “maintainability of the representation.”

At present, no fees are applicable on pre-grant opposition filings. “Absence of fees has facilitated filing of pre-grant oppositions by patient groups for access of life-saving HIV, TB, and cancer medicines over the years. Later, the availability of generics helped government-run programmes to provide affordable medicines free-of-cost to patients. Dilution of the rule will be detrimental to public health,’’ Leena Menghaney, global IP Advisor, Medecins Sans Frontieres Access Campaign, said.

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Draft patent rules could hit public health safeguards, say expertsProposed amendments to India's patent laws have raised concerns from public health groups and patent lawyers, who argue that they could undermine public health safeguards and limit access to affordable generic medicines. The amendments could affect people's right to oppose patents before they are granted, the availability of compulsory licenses, and transparency in the patent system. Stakeholders are urging the government to revise the draft rules to protect public health and ensure access to affordable medicines. One major change is the introduction of fees for pre-grant opposition filings, which could limit access to life-saving medicines.

Draft patent rules could hit public health safeguards, say expertsPublic health groups and patent lawyers have expressed concerns about the Draft Patents (Amendment) Rules, 2023 in India. They argue that the proposed amendments could weaken public health safeguards and limit access to affordable generic medicines. Key provisions such as pre-grant opposition and transparency in the patent system are at risk of being diluted. Stakeholders are urging the government to revise the draft to protect public health and ensure access to affordable medicines. They also criticize the lack of representation from patient groups in the consultation process. Additionally, the proposed amendments suggest extending the interval for submitting working statements and removing requirements for disclosure, which could hinder the availability of essential medicines at affordable prices.

'Proposed changes in Indian Patent Rules 2023 raise concerns over access to affordable medicines'Public health groups and patent lawyers are raising concerns about the Draft Patents (Amendment) Rules, 2023 in India. They believe that these amendments could weaken public health safeguards and limit access to affordable generic medicines. Key concerns include the potential dilution of provisions for pre-grant opposition and transparency in the patent system. Stakeholders are urging the government to revise the proposed draft to protect public health and ensure access to affordable medicines. The amendments also propose extending the interval for submitting working statements and removing the requirement to disclose how patents are being worked, which could hinder the availability of essential medicines.